Evidence lineage

From source artifacts to reviewable submission support.

Evidence enters once, claims stay traceable, review is controlled, and exports carry a clear use boundary.

Source evidenceStudy, CMC, safety, model, endpoint, CDISC, stability, and literature artifacts.
Claim matrixSource, uncertainty, owner, CTD placement, model version, and dataset version.
Readiness scoreScientific, document, traceability, CTD, review, agency, and submission dimensions.
Reviewer controlRoles, comments, requested revisions, issue status, and sign-off readiness.
Export packageCTD plan, evidence manifest, documents, audit trail, and downstream handoffs.
Package readiness82%Strong draft, QA sign-off pending
Evidence artifacts14Sources registered in the package spine
CTD modules mapped5Regional Module 1 through Module 5
Open review issues3Tracked before export reliance
Guided workflow

Move from master data to controlled export without losing accountability.

Use the sequence to move a package from source context to reviewable export while preserving owners, assumptions, and open issues.

1

Master data

Lock sponsor, product, application, sequence, agencies, studies, sites, and commitments.

Start
2

Evidence map

Register source artifacts and connect claims to CTD locations, uncertainty, and owners.

Map
3

Readiness score

Separate scientific, document, traceability, technical, review, agency, and submission readiness.

Score
4

Reviewer workflow

Assign roles, comments, issue closure, requested revisions, and sign-off status.

Review
5

CTD assembly

Build module tree, lifecycle operation, artifact manifest, and technical validation checklist.

Assemble
6

Export and handoff

Send package context to Submission Suite, Calendar, ModelOps, and controlled archive workflows.

Handoff
Review-ready packet

What a Bayes Pharma.ai regulatory package should contain.

Each package is built around inspectable artifacts that can be routed, reviewed, exported, and handed off with a clear boundary.

Program master data

Sponsor, product, active substance, application, agency, sequence, studies, sites, and commitments.

Multi-dimensional readiness

Separate readiness dimensions instead of one flattened confidence score.

Claim-to-evidence matrix

Every major statement linked to source, uncertainty, CTD placement, owner, and reviewer action.

CTD assembly plan

Module tree, regional Module 1 needs, lifecycle operation, artifact manifest, and validation issues.

Role-based review

Author, scientific reviewer, regulatory reviewer, quality reviewer, and approver boundaries.

Export package

JSON, markdown, HTML, CSV, evidence manifest, open issues, and compliance boundary.

Compliance boundary

Clear enough for serious regulatory buyers.

Bayes Pharma.ai separates authoring and readiness support from sponsor validation, formal eCTD publishing, and agency submission authority.

Supported today

  • Source-backed authoring support
  • Program evidence organization
  • Readiness and CTD planning
  • Reviewer workflow preparation
  • Controlled export package support

Requires sponsor validation

  • Final regulatory strategy
  • Medical writing sign-off
  • Clinical, CMC, safety, statistics, quality, and legal review
  • Formal eCTD technical validation
  • SOP and quality-system alignment

Not positioned as

  • Direct agency gateway transmission
  • Automatic acceptance guarantee
  • Certified eCTD publishing engine
  • Replacement for qualified regulatory judgment
  • Replacement for sponsor-controlled procedures
Global agency planning

Make the agency lens visible before teams enter a workbench.

Select an agency to preview the planning emphasis, expected documents, clocks, and dependencies.

Connected handoffs

Authoring context should keep moving after export.

Authoring creates the package context, then downstream workspaces use the same evidence spine for assembly, calendars, ModelOps, and archive workflows.

AuthoringMaster data, claims, readiness, roles.Open
ExportJSON, markdown, HTML, CSV package outputs.Create
Submission SuiteCTD tree, artifact manifest, lifecycle plan.Assemble
CalendarAgency deadlines, owners, escalation actions.Plan
ModelOpsContext of use, model versions, reuse limits.Govern
Workspaces

Primary package tools first. Supporting controls around them.

Start with primary package tools, then move into operations and evidence-control workspaces as the package matures.

BayesPharma Innovator - regulatory evidence preparation, source-backed authoring, reviewer workflow, and submission package readiness for accountable teams.